TECNIS® Intraocular Lens for Cataracts

No longer recruiting at 10 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Surgical Vision, Inc.

Must not be taking: Vision-affecting medications

Disqualifiers: Poorly controlled diabetes, uncontrolled eye pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of lens, the TECNIS® Next-Generation Intraocular Lens, for individuals with cataracts. The goal is to compare the effectiveness of this new lens to the standard lens used in cataract surgery. Participants will be randomly assigned to receive either the new lens or the standard control lens. The study seeks individuals with cataracts in both eyes who are not currently participating in another clinical study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance cataract treatment options.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications, but you cannot participate if you are taking medication that may affect vision.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot participate if you are taking medication that may affect vision.

What prior data suggests that the TECNIS® Next-Generation Intraocular Lens is safe for cataract treatment?

Research has shown that the TECNIS® Next-Generation Intraocular Lens (IOL), including versions like TECNIS Eyhance, has undergone safety testing in several studies. These studies suggest that the lens is safe for use in cataract surgeries. Specifically, the enhanced monofocal toric IOL proves both safe and effective, particularly for patients with astigmatism, a condition where the eye doesn't focus light evenly.

While some studies note that the specific design benefits of the TECNIS Eyhance haven't been fully proven in clinical trials, no strong evidence indicates major safety issues. The lens is generally well-tolerated, causing few negative side effects, making it a promising choice for those considering cataract surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TECNIS® Next-Generation Intraocular Lens (IOL) for cataracts is unique because it offers advancements in lens technology that aim to improve visual outcomes. Unlike traditional IOLs, which often focus solely on basic vision correction, this new lens design targets enhanced clarity and contrast sensitivity, potentially offering a more natural visual experience. Researchers are particularly excited about its ability to reduce visual disturbances such as halos and glare, which are common complaints with standard options. This could lead to improved satisfaction and quality of life for those undergoing cataract surgery.

What evidence suggests that the TECNIS® Next-Generation Intraocular Lens is effective for cataracts?

This trial will compare the TECNIS® Next-Generation Intraocular Lens (IOL) with a control IOL. Research has shown that the TECNIS® Next-Generation IOL holds promise for people undergoing cataract surgery. Studies have found that the Tecnis Eyhance IOL improves vision at both middle and close-up distances, reducing the need for glasses after surgery. Additionally, the lens remains stable in the eye, which is crucial for maintaining clear vision over time. Overall, these findings suggest that this lens could be a good option for enhancing vision after cataract surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Surgical Vision, Inc.

Are You a Good Fit for This Trial?

This trial is for English-speaking adults at least 22 years old with cataracts in both eyes who can sign consent and attend follow-up visits. It's not suitable for those unable to comply with the study procedures or complete questionnaires.

Inclusion Criteria

I am at least 22 years old.

Patient must sign the written informed consent

Patient must understand, read, and write English to complete informed consent and questionnaires

Exclusion Criteria

Patient currently participating in any other clinical study or have participated in a clinical study during the last 30 days

Patient is pregnant, plans to become pregnant during the study, or is breastfeeding

I have uncontrolled eye pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TECNIS® Next-Generation Intraocular Lens or control lens

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• TECNIS® Next-Generation Intraocular Lens

Trial Overview The study compares two types of intraocular lenses (IOLs) used in cataract surgery: a control lens (Model DCB00) and a test lens (Model DEN00V). Participants will be randomly assigned to receive one of these lenses, in a masked setup where the sponsor, subjects, and evaluators do not know which lens is given.

How Is the Trial Designed?

Group I: Test IOL Experimental Treatment 1 Intervention

DEN00V

Group II: Control IOL Active Control 1 Intervention

DCB00

TECNIS® Next-Generation Intraocular Lens is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as TECNIS Eyhance for:

• Cataract correction

Approved in United States as TECNIS Eyhance for:

• Cataract correction

Approved in Canada as TECNIS Eyhance for:

• Cataract correction

Who Is Running the Clinical Trial?

Johnson & Johnson Surgical Vision, Inc.

Lead Sponsor

Trials

40

Recruited

8,800+

Published Research Related to This Trial

The TECNIS toric intraocular lenses (IOLs) significantly reduced ocular astigmatism, with a mean reduction of 74.53% in patients requiring lower cylinder correction (0.75 to 1.50 diopters) compared to only 31.61% in those with standard IOLs, indicating their superior efficacy.

A high percentage of patients achieved excellent uncorrected distance visual acuity (UCDVA), with 43.6% of those with TECNIS toric IOLs reaching 20/20 vision or better, demonstrating both safety and effectiveness in treating cataract patients with corneal astigmatism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of TECNIS toric intraocular lens implantation after cataract removal in patients with corneal astigmatism. Waltz, KL., Featherstone, K., Tsai, L., et al.[2022]

The TECNIS Eyhance™ intraocular lens (IOL) with slight monovision in the non-dominant eye improved uncorrected intermediate and near visual acuity compared to bilateral emmetropia, with statistically significant results (p = 0.02 and 0.01, respectively).

Despite the visual improvements in the Monovision group, both groups reported similar satisfaction levels and low contrast visual acuity, with 82% of all subjects expressing happiness with their lens choice, indicating the IOL's effectiveness and patient acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Visual Performance and Subjective Outcomes with an Enhanced Monofocal Intraocular Lens When Targeted for Emmetropia or Monovision. Sandoval, HP., Potvin, R., Solomon, KD.[2023]

The TECNIS Eyhance Toric II intraocular lens demonstrated excellent rotational stability, with an average rotation of only 1.34 degrees over 3 months, and no patients required repositioning of the lens.

Patients experienced significant improvements in visual acuity and a reduction in refractive cylinder, indicating both efficacy and a good safety profile, as no adverse events were reported during the study involving 50 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rotational stability of a new toric intraocular lens with an advanced optical profile. Zeilinger, J., Hienert, J., Ruiss, M., et al.[2023]

The Tecnis Eyhance (ICB00) intraocular lens significantly improved uncorrected intermediate visual acuity compared to the conventional monofocal lens (PCB00), with average monocular UIVA of 20/32 versus 20/40 (p < 0.001).

Patients with the Tecnis Eyhance lens reported less difficulty in activities requiring intermediate vision, such as using a computer, while maintaining comparable distance visual acuity to the conventional lens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of visual outcomes after bilateral implantation of an advanced or conventional monofocal intraocular lens. Lopes, D., Loureiro, T., Carreira, R., et al.[2022]

In a study of 34 eyes from 17 cataract patients, the TECNIS Eyhance™ intraocular lens (IOL) demonstrated good intermediate visual acuity three months post-surgery, with a mean distance-corrected near visual acuity of 0.42 decimal notation for binocular vision.

The implantation of the Eyhance IOL resulted in a reduced need for additional reading power, with a mean postoperative minimum reading addition of 1.6 diopters, indicating its effectiveness in improving visual performance after cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Postoperative Total Ocular Aberrations After Bilateral Implantation of Monofocal IOL with Extended Depth of Focus in Phacoemulsification. Abd Elghaffar Shehata, M., Hosny, MH., Tolba, DA., et al.[2023]

The Tecnis® Eyhance intraocular lens (IOL) demonstrated significantly better uncorrected and distance-corrected intermediate visual acuity compared to the standard Tecnis® 1-piece IOL in a study of 64 eyes from 32 patients after cataract surgery.

Patients with the Tecnis® Eyhance IOL also experienced greater spectacle independence and better tolerance to residual refractive errors, suggesting it may be a more effective option for improving visual outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of new monofocal innovative and standard monofocal intraocular lens after phacoemulsification. Unsal, U., Sabur, H.[2021]

The Tecnis(®) Multifocal Intraocular Lens is designed to enhance vision quality and reduce spherical aberration, aiming to provide patients with a broader range of focus after cataract surgery.

This lens design reflects the growing demand for presbyopia-correcting solutions, highlighting its potential to help patients achieve spectacle independence, which is a key goal in modern cataract surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient acceptability of the Tecnis multifocal intraocular lens. Sood, P., Woodward, MA.[2021]

The TECNIS toric II intraocular lens (IOL) demonstrated significantly better rotational stability compared to the previous model (toric I), with less axis misalignment observed at both 1 day and 1 month post-surgery in a study involving 101 patients.

Despite the improved stability of the toric II IOL, there were no significant differences in visual acuity or residual astigmatism between the two IOL models, indicating that the new design primarily enhances stability without compromising other outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Modified Haptics on Surgical Outcomes and Rotational Stability of Toric Intraocular Lens Implantation. Osawa, R., Sano, M., Yuguchi, T., et al.[2023]

Citations

1. nature.com nature.com/articles/s41598-024-65746-2

Real-world outcomes of cataract surgeries using a new ... In this research, the Eyhance Toric II IOL exhibited significantly better defocus at − 1.5 D and − 2.0 D and significantly superior uncorrected ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10152560/

Real world outcomes of the new Tecnis Eyhance IOL - PMC The Tecnis Eyhance was more effective for intermediate and near vision. The central defocus of the lens might help patients achieve spectacle independence and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12402707/

Rotational Stability and Subjective Results of Tecnis Eyhance ... The data from this study suggest that the Tecnis Eyhance toric II IOL exhibits good postoperative rotational stability and positive patient- ...

4. nature.com nature.com/articles/s41433-025-03625-4

Visual and patient-reported outcomes of an enhanced ... In summary, enhanced IOLs provide improved intermediate and near visual acuities compared to conventional monofocal IOLs, though further studies ...

5. researchgate.net researchgate.net/publication/395009652_Rotational_Stability_and_Subjective_Results_of_Tecnis_Eyhance_Toric_II_Intraocular_Lens

(PDF) Rotational Stability and Subjective Results of Tecnis ... Purpose This study aims to evaluate rotational stability and patient-reported outcomes associated with Tecnis Eyhance toric II “monofocal ...

6. withpower.com withpower.com/trial/phase-cataract-5-2024-cf4b0

TECNIS® Intraocular Lens for Cataracts · Info for Participants The safety data for the TECNIS Intraocular Lens, including versions like TECNIS Eyhance and TECNIS Eyhance Toric II, has been evaluated in several studies.

7. healio.com healio.com/hosted%20sites/2024/he_a358_jandj/a358

TECNIS EyhanceTM IOLs Distance Plus, Without ... The safety and effectiveness of the TECNIS Eyhance™ IOL has not been substantiated in clinical trials and the effects of the optical design on ...

8. eyesoneyecare.com eyesoneyecare.com/resources/ultimate-guide-post-op-refraction-tecnis-family-iols/

The Ultimate Guide to Post-Op Refraction for the TECNIS ... Discover good practices for optometrists seeing post-op cataract patients, plus important considerations in premium IOL design and special refractive ...